A Multi-center Study to Evaluate the Safety, Tolerability and Efficacy of TIN816 in Patients at Risk for Acute Kidney Injury Following Cardiac Surgery.
Phase 2
Terminated
NCT05524051
| Condition | Acute Kidney Injury Following Cardiac Surgery |
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| Phase | Phase 2 |
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| Sponsor | Novartis Pharmaceuticals |
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| Status | Terminated |
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| Enrollment | 102 participants |
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| Interventions | TIN816 |
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| Start date | Mar 3, 2023 |
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| Completion date | Mar 26, 2025 |
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| Results posted | Apr 2, 2026 |
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Summary
This was a randomized, multi-centric, placebo-controlled, participant and investigator-blinded study to evaluate the safety, tolerability and efficacy of TIN816 in adult patients at risk for acute kidney injury following cardiac surgery.
Ratio of the Highest Serum Creatinine Value up to and Including Study Day 6 Versus Baseline
Baseline, Day 1 - Day 6 · ratio
| TIN816 2 mg/kg | 1.215 ratio |
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| TIN816 4 mg/kg | 1.318 ratio |
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| Placebo | 1.226 ratio |
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| p-value | 0.4543 |
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| geometric mean ratio | 0.991 (95% CI 0.87–1.13) |
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Open in BENITIONS
View on ClinicalTrials.gov
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